PIOGLITAZONE IN HEPATITIS C: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUD

吡格列酮治疗丙型肝炎：随机、双盲、安慰剂对照研究

• 批准号: 7376622
• 负责人: HARI S CONJEEVARAM
• 金额: $ 4.5万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376622
• 关键词: fats; fatty liver; hepatitis C; insulin sensitivity /resistance; liver; placebos; scars

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There have been several studies that link the presence of fatty liver in patients with viral hepatitis C and the amount of scarring or disease progression in the liver. This accumulation of fat in the liver may be due to insulin resistance. In this study, we would like to test whether patients treated with an FDA approved drug for diabetes, Pioglitazone (or Actos) will: A. Help reduce insulin resistance, which has been shown to be a key factor in causing fatty liver in patients with non-alcoholic fatty liver disease. B. Assess whether the amount of fat in the liver improves during drug treatment, which may improve the amount of fibrosis (or scarring) in the liver. C. Discover if patients being treated with Actos along with the established combination therapy, Ribaviron and Interferon, will respond better overall, to treatment for viral hepatitis C. We plan to conduct a double-blind, placebo controlled study where the subject will undergo the normal 48 weeks of treatment for hepatitis C, in addition to the study medication (pioglitazone or placebo) with histologic evaluation of the liver before treatment and at the end of 48 weeks of therapy in the study in order to assess histologic improvement.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。有几项研究表明，病毒性丙型肝炎患者的脂肪肝与肝脏的疤痕数量或疾病进展有关。肝脏中脂肪的堆积可能是由于胰岛素抵抗。在本研究中，我们想测试接受FDA批准的糖尿病药物吡格列酮（或Actos）治疗的患者是否会：a .帮助降低胰岛素抵抗，胰岛素抵抗已被证明是导致非酒精性脂肪肝患者脂肪肝的关键因素。B.评估药物治疗期间肝脏脂肪量是否改善，这可能改善肝脏纤维化（或瘢痕形成）的数量。我们计划进行一项双盲、安慰剂对照研究，受试者将接受正常的48周丙型肝炎治疗。此外，研究用药（吡格列酮或安慰剂）在治疗前和48周治疗结束时对肝脏进行组织学评估，以评估组织学改善。